Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection

• Sponsor: CytoDyn, Inc.
• Information provided by (Responsible Party): CytoDyn, Inc.

Study Description

Brief Summary:

This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on combination antiretroviral therapy.

Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one week overlap of existing retroviral regimen and PRO 140 at the beginning of the study treatment, and one week overlap at the end of the treatment in subjects who do not experience virologic failure.

Condition or disease	Intervention/treatment	Phase
HIV; Human Immunodeficiency Virus	Drug: PRO 140 350mg weekly SQ injection.	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2b Study to Assess Suppression of HIV-1 Replication Following Substitution of Stable Combination Antiretroviral Therapy With a PRO 140 (Monoclonal CCR5 Antibody) Monotherapy in Adult Subjects With HIV-1 Infection
• Study Start Date: May 2014
• Actual Primary Completion Date: September 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: PRO 140; PRO 140 350mg weekly SQ injection.	Drug: PRO 140 350mg weekly SQ injection.; CCR5 Antagonist

Outcome Measures

Primary Outcome Measures :

1. Time to Virologic Failure after initiating PRO 140 monotherapy. Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. [ Time Frame: 14 Weeks ]

Secondary Outcome Measures :

1. Proportion of Participants with Virologic Failure after initiating PRO 140 monotherapy at or prior to Week 14. [ Time Frame: 14 Weeks ]
2. Mean change in Viral Load (HIV-1 RNA levels), at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ]
3. Mean change in Viral Load (HIV-1 RNA levels), within the 14-week treatment phase [ Time Frame: 14 Weeks ]
4. Mean change in CD4 cell count, at each visit within the 14-week treatment phase [ Time Frame: 14 Weeks ]
5. Mean change in CD4 cell count, within the 14-week treatment phase [ Time Frame: 14 Weeks ]

Other Outcome Measures:

1. Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale) and by investigator-evaluation of injection site reactions. [ Time Frame: 14 Weeks ]
2. Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale [ Time Frame: 14 Weeks ]
3. Frequency of Treatment-emergent serious adverse events [ Time Frame: 14 Weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Males and females, age ≥18 years
2. Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay
3. On stable antiretroviral therapy for last 12 months
4. Subject has two or more potential alternative antiretroviral regimen options to consider.
5. No documented detectable viral loads (HIV-1 RNA <50 copies/ml) within the last 12 months prior to Screening Visit
6. Nadir CD4 cell count of >200 cells/mm3

Exclusion Criteria:

1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay at the Screening Visit
2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg)
3. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition
4. Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including PRO 140.
5. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Contacts and Locations

Locations

United States, California

Quest Clinical Research

San Francisco, California, United States, 94115

Sponsors and Collaborators

CytoDyn, Inc.

Investigators

• Principal Investigator: Jacob Lalezari, MD

More Information

• Responsible Party: CytoDyn, Inc.
• ClinicalTrials.gov Identifier: NCT02175680 History of Changes
• Other Study ID Numbers: PRO 140_CD 01
• First Posted: June 26, 2014
• Last Update Posted: December 15, 2016
• Last Verified: December 2016

Keywords provided by CytoDyn, Inc.:

HIV-1; HIV; Treatment Substitution; PRO 140; PRO140; CytoDyn; Amarex

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Slow Virus Diseases; PRO-140 monoclonal antibody; HIV Antibodies; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs